Nanosystems have been extensively investigated for drug delivery;however, there is a challenge in transferring nanotechnology from research laboratories into pharmaceutical industry. The scientific basis for this proposal originated from our three-phase nanoparticle engineering (3PNE) method recently developed which includes phase 1, amorphous precipitate;phase 2, hydrated amorphous aggregate;and phase 3, stabilized nanocrystals (NCs). The 3PNE has been applied to the development of nanocrystals for the effective delivery of the anticancer drug, Paclitaxel (PTX). This nanocrystal is unique in its simplicity, low toxicity and its high drug loading ratio. The goal of this application is to further explore this novel nanotechnology and its feasibility for commercialization for intravenous PTX delivery. To achieve this goal, the following aims are proposed. Aim 1: Develop a technology to pave the way for large scale production of PTX nanocrystals. Aim 2: Characterize the PTX nanocrystals for their pharmaceutical kinetics, bio-distribution and acute toxicity in animals. Aim 3: Establish targeted PTX nanocrystals to further increase the anti-tumor efficiency. We believe that the success of this project will accelerate the commercialization of this nanotechnology for cancer therapy. PUBLIC HEALTH RELEVANCE: Paclitaxel nanocrystals developed using the novel three-phase nanoparticle engineering (3PNE) technology have significant potential for commercialization due to their simplicity, low toxicity, and cost effectiveness. The technology lowers drug dosing and improves efficacy.